Vented medicament dispensing package with spacer

ABSTRACT

The disclosure is directed to an improvement in a universal dispensing package for medicaments to be dissolved in a parenteral container prior to use. The package is made up of a container and a cap which has a hollow piercing device for dispensing medicament from the container into a closed system parenteral solution bottle, and second has a frusto-conical shank adapted to engage the interior surface of the neck of an open system parenteral solution container. A hydrophobic membrane filter is provided as a vent in the cap to relive the vacuum to allow for dispensing of the medicament. The present improvement comprises spacers, or studs, formed at the base of the piercing device to space the hydrophobic vent at a predetermined distance from the parenteral container when used in conjunction with a closed system parenteral solution bottle.

United States Patent 11 1 Schneller et a1. 1 1 May 22, 1973 [541 VENTED MEDICAMENT DISPENSING 3,608,550 9/1971 Stanski ..128/272 PACKAGE WITH SPACER 2,778,360 1/1957 Miskel...... ..l28/2l8 D 3,050,061 8/1962 Goyke ..l28/272 Inventors: George Schneller, Devon; p 2,884,924 5/1959 Shaw ..l28/2l4 c S. Levi, Howard J. Levin, both of 3,484,849 12/1969 Huebner et a1... ..l28/272 Norristown; Stephen W. Goodsir, giurrish u an Kmg of Prussla an of 2,833,281 5/1958 Krdg ..l28/221 [73] Assignee: American Home Products Corporation, New York, Primary Exammer--R1chard A. Gaudet Assistant ExaminerJ. C. McGowan Filed: g- 1971 Attorney-Vito Victor Bellino et al. [21] Appl. No.. 172,805 ABSTRACT Related U'S'Applicamm Data The disclosure is directed to an improvement in a [63] Continuation-impart of Ser. No. 118,009, Feb. 23, universal dispensing package for medicaments to be 1971, which is a continuation of Ser. No. 814,424, dissolved in a parenteral container prior to use. The April 8, 1969, abandoned, which is acontinuation-inpackage is made up of a container and a cap which p of 3 5 5, 1968,3band0nedhas a hollow piercing device for dispensing medicament from the container into a closed system [52] US. Cl. ..128/272, 222/569, 141/329, parenteral olution bottle and s-gcond has a frusto- 1 1/ conical shank adapted to engage the interior surface [5 1] Int. Cl. ..A6lj l/00 of the neck of an open system parenteral solution con- [58] Field of Search ..l28/272, 214 R, 214 C, tainer. A hydrophobic membrane filter is provided as 128/2142, 221; 222/80, 8l, 189, 563, 564, a vent in the cap to relive the vacuum to allow for 569, 212; 141/22-25, 329, 19, 20, 21, 26, dispensing of the medicament.

330 The present improvement comprises spacers, or studs, formed at the base of the iercin device to s ace the [56] References cued hydrophobic vent at a pi deter iined distan ce from UNITED STATES PATENTS the parenteral container when used in conjunction with a closed system parenteral solution bottle, 3,592,245 7/1971 Levi et al ..l28/272 X 3,316,908 5/1967 Burke ..222/8l X 6 Claims, 3 Drawing Figures VENTED MEDICAMENT DISPENSING PACKAGE WITH SPACER This application is a continuation-in-part of application Ser. No. 118,009 filed Feb. 23, 1971 by Howard J. Levin and Stephen W. Goodsir which was a continuation of application Ser. No. 814,424 filed Apr. 8, 1969, and now abandoned, which was a continuationin-part of application Ser. No. 742,872 filed July 5, 1968 by Levin, and now abandoned.

The invention is directed to an improvement in a universal dispensing package for adding medicaments to parenteral solution containers. The present improvement comprises spacers, or studs, formed at the base of the piercing device to space the hydrophobic vent at a predetermined distance from the parenteral container when used in conjunction with a closed system parenteral solution bottle. The improvement is used in conjunction with a vent provided in the package for relief of vacuum which may be formed under certain conditions of use.

K It is common practice to add medicaments to parenteral solutions in their containers at the time the parenteral solutions are administered. The additives may be antibiotics such as sodium ampicillin, muscle relaxants, such as succinylcholine chloride, and others. The parenteral solution may be a saline solution, glucose-saline solution or other isotonic solution, such as is commonly employed for parenteral administration. Such solutions are usually administered intravenously but may be otherwise parenterally administered or may be used for irrigation. a The added medicaments are usually solutions, powders, or lyophilized cakes. Previously available means for bringing the powders or cakes into solution and for transferring the resulting solution to the bulk parenteral solution have been cumbersome and complicated and not devoid of risk to the sterility of the product contained.

There are two principal forms of containers for the parenteral solutions. More than half of the total market for intravenous fluids is supplied in closed system containers as they are defined below, while the remainder of the market is supplied in open system containers. There are various dispensing packages for medicamerits to be used in conjunction with parenteral solution containers. Typical packages are described in US. Pat. Nos. 2,957,501, 2,957,609, 3,059,643 and 3,143,251. There is, however, no dispensing package available which may be used conveniently with both the closed system and open system parenteral solution containers with complete assurance of maintenance of sterility.

The dispensing package is adapted to aseptically transfer its contents to both open system and closed system parenteral solution containers. The parenteral solution in aclosed system container is packaged under a partial vacuum and remains so for its shelflife. In order to use the dispensing package containing a dry medicament with a closed system parenteral solution container, it is necessary to relieve the vacuum present in the latter container. If the vacuum is not relieved,

during operation, when the piercing device of the dispensin'g package is inserted into the plug of the closed system container, the walls of the flexible dispensing container may collapse and medicament addition may not be accomplished. The present invention provides apparatus to alleviate the vacuum present in the closed system parenteral solution container after the dispens: ing package has been introduced by insertion of the piercing device into the former. Vacuum relief allows for equilibration and the attainment of atmospheric pressure both in the closed system parenteral solution container and in the dispensing package.

It is an object of the present invention to provide apparatus for the addition of medicaments to both open and closed system containers of parenteral solution which provides for the filtration of the medication added to the parenteral solution and for the relief of any vacuum present.

It is another object of the present invention to provide a universal dispensing package for medicaments which are to be added to parenteral solutions which may be used with powders that are not free flowing or are hygroscopic, and can be used with liquids and nonhygroscopic powders as well.

It is another object of the present invention to provide a method of dissolving medicaments in a parenteral solution in a convenient aseptic manner and which provides control of the particulate matter contributed by the added medication.

It is an object of the present invention to provide apparatus for the relief of vacuum during the addition of medicaments from a dispensing package to both open and closed system containers of intravenous parenteral solutions.

Other and further objects of the present invention will be apparent to those skilled in the art from reading the following descriptions taken in conjunction with the drawings in which:

FIG. 1 is a view, partially in cross-section and partially in elevation of a preferred embodiment of the present invention;

FIG. 2 is a view, partially in cross-section and partially in elevation taken generally along lines 2-2 of FIG. 1;

FIG. 3 is a sectional view, taken generally along lines 3-3 of FIG. 1.

The objects of the present invention may be accomplished by providing a vent and spacers adjacent the base of the conduit in a medicament dispensing package which is made up of a reservoir adapted to contain the medicament, a fitment connected to the reservoir and containing a conduit adapted to:convey the medicament from the reservoir to a parenteral solution container, and means to retain the medicament in the reservoir during storage.

In a preferred embodiment for use with a closed system parenteral solution container, the vent is located in the top of the fitment and spacers are provided adjacent the base of the conduit to space apart the vent and the top of the closed system parenteral solution container.

The characterizing feature of the present invention is comprised of the spacers 50, 52 which are formed in fitment 114 at the base 51, or proximal end with regard to the container 112, of the piercing device 130. The spacers 50, 52 are connected to the piercing device and the top of the shank 138. The spacers may be of any shape to serve the function of spacing the vent filter 144 from the top of a closed system parenteral solution container. A preferred embodiment is shown in FIGS. 1, 2 and 3.

Spacer 50 is formed with side surfaces 54, 56 and top surface 58. The height of the spacer 50 is predetermined to be distance H above top surface 60 surrounding the vent filter 144, as further described below. Side surfaces 54, 56 are joined at one end to the piercing device 130 and preferably are rounded to an end portion 62.

Similarly spacer 52 is formed with side surfaces 64, 66 and top surface 68, which is at the same height as top surface 58 as described above. Side surfaces 64, 66 are joined at one end to the piercing device 130 and preferably are rounded to an end portion 70.

The height H as shown in FIG. 1 may be any distance large enough to permit ingress of atmosphere into the filter 144. Typically the distance is about one-sixteenth of an inch or greater.

A preferred embodiment is shown in FIG. 1 in which the air vent is located adjacent the piercing device and spacers are placed adjacent the base of the piercing device. As is shown in FIG. 1 the package 110 is made up of a container 112, a fitment 114 and an outer sheath 116. Medicament 117 is contained in container 112. Adjacent its distal or discharge end 118, the container 112 has a plurality of ribs, or fluting, 120 adapted to engage interior surfaces of an open system parenteral solution container. The container 112 also has an annular sealing rib 122 defined in it, as further described below. Adjacent the distal end 118, a seat is defined by annular surfaces 124, 126, and a mounting rib 128 is defined adjacent surface 126.

The fitment 114 is made up of a shank 138 and a piercing device 130 disposed off-center of the axis 132 of the package 110. The shank 138 has an interior surface 137 defining an interior cavity 139. The piercing device 130 has a conduit 134 defined in it. The contents of the package may be discharged by passing through the interior cavity 139 and the conduit 134.

An orifice 136 is defined in the shank 138 of the fitment 114. The orifice 136 has surfaces 140 and 142 defined in it to form a seat for the filter 144 which may be fastened in place as a press-fit or in other wellknown fashion, for instance, by heat-sealing, solventsealing or ultrasonic-sealing.

The seat may be omitted if desired, for instance, where the filter 144 is of small size. An annular rib 146 and an annular groove 148 are defined on the outer surface of the shank 138 and cooperate with the surfaces 124, 126 and the mounting rib 128 of the container 112 to engage each other and hold the container 112 and fitment 114 in fixed relationship. Beveled surface 150 adjacent proximal surface 152 of the shank 138 provides a guide for easy snap-in insertion of the cap into the container. If desired, a membrane filter 153 may be mounted on the proximal surface 152.

The distal end 154 of the piercing device 130 is tapered to assist piercing and, if desired, to cooperate with the outer sheath as is described, in application Ser. No. ll8,009 filed Feb. 23, 1971 by Levin and Goodsir.

In use when the medicament 117 is dry, the walls of the container 112 may be compressed and the distal end of the conduit 154 submerged in the liquid of a closed system parenteral solution bottle. A suitable portion of the liquid may be drawn into the container 112 in order to dissolve the dry medicament. To make this possible it may be necessary to relieve any vacuum present. Relief of vacuum is accomplished by the hydrophobic vent 144. The reconstituted medicament solution may be discharged from the package by compressing the sides of the container 112. The medicament 117 passes through the filter 153, when present, where any particles are removed.

The container 112 is preferably made of polyethylene, or similar elastically recoverable material but may also be made of rigid material such as glass, if desired. The fitment 114 is preferably made of Delrin, an acetal polymer of formaldehyde, but may be made of any other suitable plastic, such as polyethylene, or metal. The piercing device is typically made of the same material as the remainder of the fitment 114, but if desired may be of a different material, such as a metal or alloy.

The vent filter may be any suitable material, including sintered glass. Hydrophobic membrane filters are preferred. Membrane filters are a class of thin filters composed of a porous matrix wherein the size of the pores prevents any insoluble matter larger than the pores from passing through the filter. When used for sterilization, membranes are composed of pores small enough to prevent the passage of microorganisms and thus render the solution sterile. The membrane filter is usually composed of cellulose esters such as cellulose acetate, cellulose triacetate, cellulose nitrate, combination of cellulose acetate and nitrate, regenerated cellulose, polyethylene, nylon, Teflon, polyvinyl chloride, fluorinated vinyl, polypropylene, epoxy glass, acrylic vinyl copolymer, or the like.

A preferred material for the vent filter is acrylicnitrile-polyvinyl chloride copolymer reinforced with nylon and rendered hydrophobic to prevent the passage of aqueous solutions. The filter may be made hydrophobic by treatment with silicones. The liquid filter is preferably made of the same material.

The membrane filters useful in the practice of the present invention customarily range in thickness from 25 to 300 microns and have a mean pore size range from about 0.005 micron to 10 microns, preferably from about 0.2 micron to 10 microns. The filter may assume a variety of designs and embodiments to accomplish its function.

Filters having a mean pore size range of 0.005 to 10 microns are commercially available. Filters having a mean pore size smaller than about 0.2 micron sterilize liquids by removing microorganisms. In some cases, filters having larger mean pore sizes up to about 1.2 microns will sterilize air. Vent filters having a mean pore size range of about 0.2 to 5 microns are particularly useful in the preferred embodiment. The preferred mean pore size for a liquid filter is 3 to 10 microns.

The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but is recognized that various modifications are possible within the scope of the invention claimed.

What is claimed is:

l. A medicament-dispensing package for use with a parenteral solution container comprising:

A. A variable volume reservoir adapted to contain a medicament;

ii. A plurality of spaced sealing members defined on the distal end of said reservoir and adapted to engage the interior surfaces of an open system parenteral solution container;

B. A single fitment connected to said reservoir and further comprising a conduit adapted to convey said medicament from said reservoir to the parenteral solution container;

i. Said conduit being located on the proximal end of said fitment and located offcenter of said fitment;

ii. An orifice defined in the proximal end of said fitment and adapted to receive a vent filter;

C. Means connected to said fitment and adapted to sealably engage a closed system parenteral solution container;

D. A vent filter mounted in said orifice in the proximal end of said fitment and adapted to equalize pressure within and without said reservoir;

i. Said vent filter being located offcenter of said fitment opposite said offcenter conduit;

B. At least one spacer connected to said fitment and extending axially away from said fitment adjacent to said offcenter conduit, said spacer being higher than the vertical height of the vent filter mounting and adapted to space said vent filter a predetermined distance from a closed parenteral solution bottle; and

F. Means to retain the medicament in said reservoir.

2. A package as defined in claim 1 wherein said vent filter is comprised of a hydrophobic membrane.

3. The package as defined in claim 1 in which said spacer provides a predetermined distance of at least one-sixteenth inches.

4. The package as defined in claim 2 wherein said medicament retaining means is a hydrophobic mem' brane filter. i

5. The package as defined in claim 2 wherein said vent filter has a mean pore size of about 0.2 to 1.2 microns.

6. The package as defined in claim 4 wherein the pore size of said retaining membrane filter is about 3 to 10 microns. 

1. A medicament-dispensing package for use with a parenteral solution container comprising: A. A variable volume reservoir adapted to contain a medicament; ii. A plurality of spaced sealing members defined on the distal end of said reservoir and adapted to engage the interior surfaces of an open system parenteral solution container; B. A single fitment connected to said reservoir and further comprising a conduit adapted to convey said medicament from said reservoir to the parenteral solution container; i. Said conduit being located on the proximal end of said fitment and located offcenter of said fitment; ii. An orifice defined in the proximal end of said fitment and adapted to receive a vent filter; C. Means connected to said fitment and adapted to sealably engage a closed system parenteral solution container; D. A vent filter mounted in said orifice in the proximal end of said fitmEnt and adapted to equalize pressure within and without said reservoir; i. Said vent filter being located offcenter of said fitment opposite said offcenter conduit; E. At least one spacer connected to said fitment and extending axially away from said fitment adjacent to said offcenter conduit, said spacer being higher than the vertical height of the vent filter mounting and adapted to space said vent filter a predetermined distance from a closed parenteral solution bottle; and F. Means to retain the medicament in said reservoir.
 2. A package as defined in claim 1 wherein said vent filter is comprised of a hydrophobic membrane.
 3. The package as defined in claim 1 in which said spacer provides a predetermined distance of at least one-sixteenth inches.
 4. The package as defined in claim 2 wherein said medicament retaining means is a hydrophobic membrane filter.
 5. The package as defined in claim 2 wherein said vent filter has a mean pore size of about 0.2 to 1.2 microns.
 6. The package as defined in claim 4 wherein the pore size of said retaining membrane filter is about 3 to 10 microns. 